A prospective and randomized study of conversion from tacrolimus to cyclosporine A to improve glucose metabolism in patients with new-onset diabetes mellitus after renal transplantation (REVERSE study) - REVERSE

B Erasme0 个研究点目标入组 200 人开始时间: 2008年5月27日最近更新: 2018年8月20日

试验速览

暂无简介。

•Diabetes mellitus difined by: At least 2 fasting blood glucose levels >= 126mg/dl or any glucose level >= 200 mg/dl in presence of polyuria/polydipsia or a glucose level 2 hours after a 75g OGTT>=200mg/dl during the three months before inclusion or ongoing treatment with oral agents and/or insulin at inclusion.
•first or second renal transplantation more than 6 monthes before inclusion
•Minimal clinically acceptable steroid dose during the last 3 months before inclusion.
•Treatment with tacrolimus
•Patients 18 years or older.
•Women must be willing to use efficient contraception for the duration of the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Medical history of diabetes before renal transplantation
•Multi-organ transplants
•Uncontrolled arterial hypertension
•Hypercholiesterolemia that is not controlled by medical therapy.
•Acute rejection treated with bolus corticosteroids during the previous 3 months
•history of more than two episodes of treated acute rejection.
•Monotherapy with tacrolimus
•Treatment with tacrolimus in combination with sirolimus.

发起方

B Erasme